Provatine Capsule 20mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Fluoxetine HCl

Boleh didapati daripada:

DUOPHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

Fluoxetine HCl

Unit dalam pakej:

30 mcg/mL; 100 Capsule Capsules

Dikeluarkan oleh:

DUOPHARMA (M) SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RIMUP)_
1
PROVATINE CAPSULE
Fluoxetine (20mg)
WHAT IS IN THE LEAFLET?
1.
What PROVATINE is used
for
2.
How PROVATINE works
3.
Before
you
use
PROVATINE
4.
How to use PROVATINE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
PROVATINE
8.
Product Description
9.
Manufacturer & Product
Registration Holder
10.
Date of Revision
WHAT
PROVATINE IS USED
FOR
PROVATINE is normally used
to
treat
depression
and
the
anxiety
associated
with
depression, in adults. It is also
used
to
obsessive-compulsive
disorder
and
pre-menstrual
dysphoric disorder (PMDD), a
severe
form
of
premenstrual
syndrome (PMS).
Your
doctor
may
have
prescribed
PROVATINE
for
another
reason.
Ask
your
doctor
if
you
have
any
questions
about
why
PROVATINE
has
been
prescribed for you.
PROVATINE is available only
with a doctor’s prescription.
The
use
of
this
medicine
in
children and adolescents under
the
age
of
18
years
is
not
recommended.
HOW PROVATINE WORKS
PROVATINE
contains
fluoxetine
hydrochloride.
It
belongs
to
a
group
of
medicines known as selective
serotonin
reuptake
inhibitors
(SSRIs).
PROVATINE
affects
chemicals in the brain that may
become unbalanced and cause
depression,
panic,
anxiety,
or
obsessive
compulsive
symptoms.
BEFORE YOU USE PROVATINE
-
_When you must not use it_
_ _
Do
not take
this
medicine
if
you are allergic to fluoxetine or
any of the ingredients listed at
the end of this leaflet.
Do
not
take
PROVATINE
if
you
are
taking
another
medicine for depression called
a monoamine oxidase inhibitor
(MAOI) or have been taking a
MAOI within the last 14 days.
MAOI
includes isocarboxacid,
linezolid,
phenelzine,
rasagiline,
selegiline
and
tranylcypromine.
Do
not
take
PROVATINE
if
you
are
taking
another
medicine that affects the level
of
a
chemical
in
the
brain
called serotonin.
Ask your doctor or pharmacist
if you are unsure as to whether
or not you are taking a MAOI
or other medicine that affects
serotonin in the brain.
Do not use this medicine after
the expiry date printed on the
pack or

Ciri produk

[DUOPHARMA (M) SDN BHD]
Page 1 of 3
[REVISION DATE: 05.01.2022]
PROVATINE CAPSULE 20MG
DESCRIPTION:
A green/ cream, size ‘3’ capsule with markings ‘DUO 861’.
COMPOSITION:
Each capsule contains Fluoxetine HCl equivalent to Fluoxetine 20mg.
Gelatin for Capsule: Halal certified bovine source.
PHARMACODYNAMICS:
The antidepressant and antiobsessional action of fluoxetine is
presumed to be linked to its inhibition of CNS neuronal uptake of
serotonin. Studies at clinically relevant doses in man have
demonstrated that
fluoxetine blocks the uptake of serotonin, but not of noradrenaline,
into human platelets. Studies in animals also suggest that fluoxetine
is a much more potent uptake inhibitor of serotonin than of
noradrenaline.
Antagonism of muscarinic, histaminergic, and α 1-adrenergic receptors
has been hypothesised to be associated with various anticholinergic,
sedative, and cardiovascular effects of classical tricyclic
antidepressant drugs. Fluoxetine binds to these and other membrane
receptors from brain tissue much less potently in vitro than do the
tricyclic drugs.
PHARMACOKINETICS:
Absorption: In man, following a single oral 40 mg dose, peak plasma
concentrations of fluoxetine from 15 to 55 ng/mL are observed after 6
to 8 hours. Fluoxetine is 80 to 95% absorbed following oral
administration. There is a linear dose proportionality for the
absorption of fluoxetine over the therapeutic dose range. Food does
not appear to affect the systemic bioavailability of fluoxetine,
although it may
delay its absorption inconsequentially. Thus, fluoxetine may be
administered with or without food.
Distribution: The volume of distribution for fluoxetine is estimated
at 30-40 L/kg.
Protein Binding: Over the concentration range from 200 to 1,000 ng/mL,
approximately 94.5% of fluoxetine is bound in vitro to human serum
proteins, including albumin and α-l-glycoprotein. The interaction
between fluoxetine and other highly protein-bound drugs has not been
fully evaluated, but may be important (see Precautions).
Metabolism: Fluo